TY - JOUR
T1 - Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis
AU - Constantin, Tamas
AU - Foeldvari, Ivan
AU - Vojinovic, Jelena
AU - Horneff, Gerd
AU - Burgos-Vargas, Ruben
AU - Nikishina, Irina
AU - Akikusa, Jonathan D.
AU - Avcin, Tadej
AU - Chaitow, Jeffrey
AU - Koskova, Elena
AU - Lauwerys, Bernard R.
AU - Penades, Inmaculada Calvo
AU - Flato, Berit
AU - Gamir, Maria Luz
AU - Huppertz, Hans Iko
AU - Raad, Juan Jose Jaller
AU - Jarosova, Katerina
AU - Anton, Jordi
AU - Macku, Marie
AU - Otero Escalante, William J.
AU - Rutkowska-Sak, Lidia
AU - Trauzeddel, Ralf
AU - Velez-Sanchez, Patricia J.
AU - Wouters, Carine
AU - Wajdula, Joseph
AU - Zang, Chuanbo
AU - Bukowski, Jack
AU - Woodworth, Deborah
AU - Vlahos, Bonnie
AU - Martini, Alberto
AU - Ruperto, Nicolino
PY - 2016/4/1
Y1 - 2016/4/1
N2 - Objective. The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). Methods. CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). Results. There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. Conclusion. Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues. The Journal of Rheumatology
AB - Objective. The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). Methods. CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). Results. There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. Conclusion. Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues. The Journal of Rheumatology
KW - Clinical trial
KW - Enthesitis-related arthritis
KW - Etanercept
KW - Extended oligoarthritis
KW - Juvenile idiopathic arthritis
KW - Psoriatic arthritis
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U2 - 10.3899/jrheum.150430
DO - 10.3899/jrheum.150430
M3 - Article
AN - SCOPUS:84982113293
SN - 0315-162X
VL - 43
SP - 816
EP - 824
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 4
ER -